Events

Retiro De Equipo (Recall) de Fresenius 2008T Hemodialysis Machine

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Fresenius Medical Care Holdings, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68042
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1618-2014
  • Fecha de inicio del evento
    2014-04-25
  • Fecha de publicación del evento
    2014-05-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126850
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    2008-series hemodialysis machines with revision k actuator test boards may fail to detect a disconnected ultrafiltration (uf) pump.
  • Acción
    Fresenius Medical issued Urgent Recall letter issued on 4/25/14 by certified mail with signature confirmation and fax-back form. Customers instructed to examine their inventory to determine whether they have any of the affected 2008T machines or if they have installed any of the affected replacement boards. If customers have the affected machines or replacement boards, they will be instructed to contact FMC-RTG Technical Service to have the Actuator Test Boards replaced. Contact the FMCNA Technical Service Team at 1-800-227-2572.

Device

Fresenius 2008T Hemodialysis Machine
  • Modelo / Serial
    Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) and the country of Canada.*
  • Descripción del producto
    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). || Part Number: 190234 Revision K
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Dirección del fabricante
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Empresa matriz del fabricante (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA